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CMS, OIG Propose to Modify Fraud and Abuse Laws

The Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have released proposed rules in conjunction with the Department of Health and Human Services’ regulatory sprint to coordinated care. As part of the regulatory sprint, OIG and CMS in 2018 issued requests for information on promoting care coordination by eliminating barriers that might exist under current fraud and abuse laws.

Anti-Kickback Statute

The OIG’s proposed rule would modify existing safe harbor protections and add new safe harbors under the federal anti-kickback statute (AKS) for certain coordinated care and associated value-based arrangements. The rule also would add exceptions to the beneficiary inducements civil monetary penalty law that prohibits inducements offered to patients for certain patient engagement.

OIG proposes three new safe harbors for certain remuneration exchanged between or among participants in a value-based arrangements, along with a safe harbor for arrangements that engage patients more actively in preventive care and adherence to treatment and care plans. OIG also proposes a safe harbor related to cybersecurity tools and modifications to existing safe harbors related to personal services arrangements, electronic health records, warranties, and local transportation.

Additionally, OIG proposes a safe harbor related to care delivery and payment arrangements as well as beneficiary incentives for participants in CMS-sponsored models and initiatives, including Innovation Center models and the Medicare Shared Savings Program.

Any finalized safe harbors would provide only prospective protection.

Physician Self-Referral Law

CMS’ proposed rule targets undue burden of the physician self-referral law, commonly referred to as Stark. The agency proposes exceptions to Stark for certain value-based compensation arrangements between or among physicians, providers, and suppliers.

Specifically, the agency proposes three exceptions for compensation arrangements that they believe do not pose a risk of program or patient abuse, including:

  • an exception that would apply to a value-based arrangement in which a value-based enterprise has assumed full financial risk for patient care services for a target patient population;
  • an exception that would apply to a value-based arrangement under which the physician is at meaningful downside financial risk for failure to achieve the value-based purposes of the value-based enterprise; and
  • an exception that would apply to any value-based arrangement, regardless of the level of risk undertaken by the value-based enterprise, provided that the arrangement satisfies specified requirements.

These proposed exceptions include fewer requirements when a value-based enterprise has assumed full financial risk for the cost of the target patient population’s health care. The requirements increase and change as the level of financial risk in the value-based arrangement diminishes.

CMS also proposes an exception, aligned with OIG, for donations of cybersecurity technology and related services. The agency also proposes to clarify definitions for certain existing terms under Stark, including “commercially reasonable,” “volume or value standard,” and “fair market value.”

America’s Essential Hospitals is analyzing the proposed rules for comment and will send members a detailed Action Update in the coming days. Comments on the proposed rules are due to CMS and OIG Dec. 31.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Maryellen Guinan is a principal policy analyst at America's Essential Hospitals.

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